(112 days)
Self adhesive composite luting cement is a universal, self adhesive, dual-curing composite luting cement. The Self adhesive composite luting cement is indicated for the adhesive fixing of ceramic, composite and metal-based inlays, onlays, crowns, bridges and posts, screws, veneers and orthodontic appliances.
The Self adhesive composite luting cement is a dental cement that complies with the requirements set forth in the following standards: ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical . devices used in dentistry - Test methods for dental materials; ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials .
This 510(k) summary (K093338) describes a dental device, specifically a "Self adhesive composite luting cement." The provided document does not describe a study that proves the device meets acceptance criteria in the way typically expected for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices through conformity with recognized dental standards and FDA guidance documents.
Therefore, many of the requested sections related to acceptance criteria, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not applicable in this context.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of an AI/ML device performance study. For this dental cement, acceptance criteria are generally defined by performance benchmarks within the referenced ISO standards (ISO 7405:1997 and ISO 4049:2000) for biocompatibility, physical properties, and luting characteristics. The document states the device "complies with the requirements set forth in the following standards," which implies it met the acceptance criteria implicitly defined by these standards. No specific numerical performance results are reported in this 510(k) summary.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Biocompatibility (per ISO 7405:1997) | Complies with ISO 7405:1997 (implied acceptable biocompatibility) |
| Polymer-based Filling, Restorative, and Luting Material Properties (per ISO 4049:2000) | Complies with ISO 4049:2000 (implied acceptable physical and mechanical properties) |
2. Sample size used for the test set and the data provenance
Not applicable. This is a traditional medical device submission based on compliance with performance standards and substantial equivalence, not an AI/ML device evaluated with a test dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth establishment by experts is not described for this type of device submission. Performance is assessed against international standards.
4. Adjudication method for the test set
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" (or basis for verification) is established by the performance requirements and test methods defined within the referenced international standards:
- ISO 7405:1997 Dentistry Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials
- ISO 4049: 2000; Dentistry Polymer-based Filling, Restorative and Luting materials
Compliance with these standards implies the device has met the established benchmarks for safety and performance for its intended use.
8. The sample size for the training set
Not applicable. Training sets are relevant for AI/ML models, not for this type of traditional medical device.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device Submission Approach:
The K093338 submission for the "Self adhesive composite luting cement" is an Abbreviated 510(k). This type of submission relies on:
- Conformance to Recognized Standards: The primary method for demonstrating safety and performance is by showing compliance with specific FDA-recognized international standards (ISO 7405:1997 and ISO 4049:2000). These standards contain established test methods and acceptance criteria for dental materials.
- Substantial Equivalence: The device's components and indications are compared to already legally marketed predicate devices, implying similar safety and effectiveness profiles.
The document does not contain raw study data, specific performance metrics, or details of a clinical trial that would be required for an AI/ML device or a novel device proving entirely new performance claims. Instead, it asserts compliance with established standards and guides.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.